Sample Acceptance

&
Rejection Criteria

Presented By : Mr. Sayan

 Introduction
 A laboratory specimen is a sample of a medical patient’s blood, tissue, fluid, or other
material derived from the patient used for laboratory analysis, examination or study.

 In case of samples that do not meet the acceptance criteria, clients are requested to send a
fresh sample.

 A report is generated for all the samples that are rejected indicated “Test not performed”
with adequate reasons for sample rejection.

 If a repeat sample is received for such type of cases, the sample will be treated as a fresh
case and a new accession number will be generated.

 The result of any laboratory test is only as good as the sample received in the laboratory.
Workflow of Test Process
Patient identification

Blood collection process

Order of draw (As per the SOP)

Patient care during collection & post

collection

Transportation of specimen to laboratory

Specimen Rejection & Acceptance criteria

Sample Rejection Criteria
The Laboratory should establish rejection criteria and follow it closely. It is
the responsibility of the laboratory to enforce its policies on sample rejection
(International Standards) so that patient care is not compromised.

Management should regularly review the number of rejected samples and

reasons for the rejections , conduct training on sample collection , and revise
written procedures for sample management as needed.
Role of Sample Rejection Criteria

Rejection criteria are designed:

1. To prevent inaccurate report

2. To ensure the safety of patient

Sample Rejection Criteria
WRONG LABEL
QUANTITY NOT SUFFICIENT (QNS)
UNDER FILLED
CLOTTED SAMPLE
WRONG TUBE COLLECTION
OUTDATED SUPPLIES
SPECIMEN DRAWN AT WRONG TIME
CONTAMINATION SPECIMEN
DELAYED TRANSPORT TIME/SAMPLE
PROCESSING AND TEMPERATURE
CONDITION
HEMOLYSIS
LIPEMIC & ICTERIC SAMPLE
 Sample Rejection Criteria
 MISLABELED/WRONG LABELED SPECIMEN  QUANTITY NOT SUFFICIENT (QNS)

 A specimen is mislabeled if it arrives in the

laboratory with a requisition bearing
different names on the requisition and the  Check the test and sample volume if sample
label OR if the name in the computer does
not match the label. quantity is low
 Patient Identification : Patient name
 QNS : Contact the collector or the concerned
Patient Id
person and have the blood redrawn and re
Age & gender
sampling of specimen.
Barcode
 Sample Rejection Criteria
 UNDERFILLED SAMPLE  CLOTTED SAMPLE

 Underfilled tubes are the tubes which have wrong ratio

 An inappropriately clotted blood specimen is one in
of blood to anticoagulant.
which clotting occurs in a tube containing an
 Partially filled EDTA tubes affect the cells because anticoagulant.
EDTA is hypertonic (underfilled EDTA tubes
causes red cells shrink, decreasing the mean cell  A specimen clots when there is not adequate mixing
volume and increasing the mean cell corpuscular of the anticoagulant in the tube.
hemoglobin concentration).
Sample Rejection Criteria
 WRONG TUBE COLLECTION  OUTDATED SUPPLY

 The Instant rejection occurs when we are using the

It specifies when sample is collected in a wrong tube expired consumables.

 Things to monitor –
 For the example:
1. Check every date before start work ,all the
1.Chemistry sample was collected in anticoagulant vacutainers expiry date.
sample tube. 2. Remove the all-expired items in currently
used area.
2. For the coagulation test sample was received in gel
 Inaccurate test result
tube.
Sample Rejection Criteria
 SPECIMEN DRAWN AT WRONG TIME  CONTAMINATED SPECIMEN

 Contaminated samples are those where the lab gets the

 This implies the condition when sample is collected at a
w r o n g t i m e o r i n a w r o n g w a y. samples which are leaked, or urine/stool samples kept in
same bag with blood sample.
 For the example :

 IV fluid sample  Request should be submitted to provide new specimen.

 Fasting morning cortisol , FBS  Give the training /instruction to consent client/person.

 Some therapeutic drugs taken by the patient

Sample Rejection Criteria
 DELAYED TRANSPORT TIME AND SAMPLE PROCESSING

 Ideally, all samples should receive within 2-4 hours to the laboratory.
 Appropriate transport media and detailed instructions should be available for samples
transported to laboratories.
 If the time between sample collection and receipt is too long for a valid test to be performed,
then we will see the deviation in the test analyte results.
Sample Rejection Criteria
 TEMPERATURE CHANGES DURING TRANSPORTATION

Delays in transporting samples may cause inaccurate results due to fluctuations in

temperature. Samples may be exposed to light or heat during transportation, resulting in the
degradation of analytes.
Also, fluctuations in temperature of the blood samples alter the unique structure of protein
and leads to invalid results.
Each analyte has a unique stability pattern for the range of temperature.
 Sample Rejection Criteria
 HEMOLYSIS OF SAMPLE

 It is the very first criteria for the sample rejection

 A hemolyzed blood sample is when the red blood cells in the sample
you provided have burst or broken down. Hemolysis – rupture of red
blood cell (“ Hemo” = blood “ Lysis” = rupture of cell)

 Hemolysis resulting from phlebotomy, may be caused by incorrect

needle size, improper tube mixing, incorrect filling of tubes,
excessive suction, prolonged tourniquet, and difficult collection.

 Inaccurate test result

 Collect the repeat sample & do the test.

 Sample Rejection Criteria
 LIPEMIC SAMPLE  ICTERIC SAMPLE

 Lipemia is a turbidity of the sample caused by

accumulation of lipoprotein particles , especially  Icterus is caused by elevated concentrations of
chylomicrons bilirubin, which can occur in a variety of
physiologic states and disease conditions in children
 The most common cause of turbidity is a high
and adults.
concentration of triglycerides.

 The largest particles, chylomicrons, with sample size  This colour is normally due almost exclusively to the
of 70–1000 nm, have the greatest potential in causing presence of bilirubin, a hemoglobin waste product
turbidity of the sample. from the red blood cells.
Sample Rejection Criteria
For most of the parameter's serum/plasma samples are required. Properly label a
Requirement for Biochemistry Sample
serum/plasma collection tube with patient ID and collection date.
in plain tube. Gel tubes can also be used for serum separation.
Following centrifugation, it is important to immediately transfer the liquid component

For serum sample collect whole blood, allow the blood to clot by leaving it undisturbed at
room temperature. This usually takes 15-30 minutes. Remove the clot by centrifuging at
2000- 3000 rpm for 10 minutes. The resulting supernatant is designated serum.
 Requirement for Hematology & Clinical Pathology sample
Properly label specimen with patient ID and collection date

Collect whole blood in EDTA tube. Thoroughly mix whole blood sample.
For coagulation, collect whole blood in Sodium Citrate (light blue top) tube.

Patients are instructed to collect morning’s 1st voided midstream Urine and
samples are collected in a sterile & screw capped container.
Requirement for Histopathology / Cytopathology samples

 TRF fully filled with Clinical details.

 Site of Biopsy.
 Correct billing for Small/ Large / Medium / Radical.
 Check whether received in formalin or not.
 Endoscopy reports for all Gastrointestinal endoscopy cases.
 LMP and drug history for all endometrial biopsies.
 Bone marrow samples – with CBC
 Second opinion with first opinion report.
 Communication to CC / lab head for all related queries.
Properly label a blood collection tube with patient ID and collection date & time.
Requirement for Molecular Biology samples
For the test requiring whole blood, collect 5 ml whole blood in EDTA tube, using acceptable venipuncture technique.
DO NOT COLLECT BLOOD IN HEPARIN AS IT IS INHIBITOR OF PCR. Thoroughly mix whole blood sample.

For tests requiring plasma, centrifuge EDTA sample to separate plasma within 1 hour of collection.

For test performed on paraffin embedded tissue, block with more than 80% tumor cells is required which should be go with
an H&E slide of the same block. .

All samples received for HIV viral load qualitative shall be accompanied by Consent Form.
For the SARS CoV-2 COVID test require SRF ID along with the VTM sample and check the storage condition at 2 to 8 ℃
should maintain during transportation.
 Rejection and Requirement of Microbiology samples

 REJECTION  REQUIREMENTS

 Improper specimen transport .The information on Ensure that each ‘specimen’ samples should
the label doesn’t match the information on the
match with the TRF as per sample acceptance
requisition.
criteria
 Specimens and requisitions which are
Note: All the TB testing specimen
incompatible (i.e., urine specimen with
(sputum/Endometrium/pus/CSF/Fluids-
requisition checked off for sputum).
ascetic/synovial) for AFB stain/TB Bactec
 Liquid specimens which are not sent in sterile,
blood culture/TB-PCR, Nikshay ID is
dry, leakproof containers.
a mandatory requirement of any case
 Requisitions which have been contaminated with
already diagnosed as Active TB.
a liquid specimen/ Frozen specimens.
If not diagnosed yet all the proper detailed
 If specimen for culture is received in a fixative
information should be provided.
(e.g., formalin).
Sample Rejection in LIS
IT-DOSE

Sample Processing

Result Entry

Sample Rejection

Reject Category

Reject Reason
Sample Rejection Documentation
Actions for
Rejected Samples
Actions for Rejected Samples
Sample Rejection

SR Informs the CC Team about the sample rejection

Inform the Client

Request for the resample with the appropriate reason for rejection

Fresh Sample Received in Lab

Register the sample with New Accession ID

Note: Rejected samples are retained for 7 days after that discarded
ANY QUESTIONS
Thank You